Oncology experts roundtable: Practical insights on FDA draft guidance discussing OS data in cancer trials

This round table discussion is part of The Regulatory Navigator series, where we explore the evolving regulatory landscape with actionable insight from Parexel's experts, sharing their experience to maximize success for clinical development and patient access.

Hosted by former EMA regulator Sinan B. Sarac, M.D., Ph.D., SVP Head of Oncology Europe at Parexel, this roundtable discusses the recently published FDA draft guidance "Approaches to Assessment of Overall Survival in Oncology Clinical Trials.” Sinan is joined by Bernardo Haddock Lobo Goulart, M.D., VP Parexel Regulatory Consulting and former FDA regulator, and Aaron Sosa, M.D., VP Parexel Regulatory Consulting and former EMA regulator.

The FDA's new draft guidance establishes overall survival (OS) as both an efficacy and safety endpoint in oncology trials, requiring its assessment even when not the primary endpoint. Parexel's oncology experts emphasize that sponsors must pre-specify OS analysis in statistical plans with clear harm thresholds to ensure surrogate endpoints don't mask potential harm. Both FDA and EMA are aligned in this approach, recognizing that while OS may not always be feasible as a primary endpoint, it remains central to regulatory evaluation and benefit-risk assessment.

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